Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-08 @ 11:35 AM
Study NCT ID:
NCT03268733
Status:
UNKNOWN
Last Update Posted:
2017-08-31
First Post:
2017-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lipid profile', 'timeFrame': '3 months', 'description': 'Lipid profile will be compared in the treatment group and control group'}, {'measure': 'Plasma level of random glucose', 'timeFrame': '3 months', 'description': 'Plasma level of random glucose will be compared in the treatment group and control group'}, {'measure': 'Plasma level of folate', 'timeFrame': '3 months', 'description': 'Plasma level of folate will be compared in the treatment group and control group'}, {'measure': 'Plasma level of homocysteine (Hcy)', 'timeFrame': '3 months', 'description': 'Plasma level of homocysteine (Hcy) will be compared in the treatment group and control group'}, {'measure': 'Plasma level of hemoglobin (Hb)', 'timeFrame': '3 months', 'description': 'Plasma level of hemoglobin (Hb) will be compared in the treatment group and control group'}, {'measure': 'Plasma level of C-reactive protein (CRP)', 'timeFrame': '3 months', 'description': 'Plasma level of C-reactive protein (CRP) will be compared in the treatment group and control group'}], 'primaryOutcomes': [{'measure': 'pregnancy rates', 'timeFrame': '3 months', 'description': 'Pregnancy rates will be compared in the treatment group and control group'}, {'measure': 'Ovulatory pattern improvements', 'timeFrame': '3 months', 'description': 'Ovulatory pattern will be assessed based on the history of the PCOS patients, the patients whom were having baseline oligomenorrhea or amenorrhea will be re-assessed for resuming regular cycles defined as periods lasting 22 - 35 days. this pattern improvement will be compared in the treatment group and control group using questionnaire'}, {'measure': 'Clinical signs of hyperandrogenemia', 'timeFrame': '3 months', 'description': 'Hirsutism will be used as a sign of hyperandrogenemia, Patients will be provided with modified Ferriman -Gallwey (mFG) images to self-rate hair growth in each of the 9 body areas (upper lip, chin, chest, upper and lower back, upper and lower abdomen, thighs, and upper arms). For each site, a score on a scale of 0 to 4 was recorded. A total score of 8 or greater is defined as clinical evidence of hirsutism; scores from 8 to 15 are considered mild hirsutism; scores from16 to 25 are considered moderate; and scores from 26 to 36 are considered severe hirsutism. The baseline and after 3 months hirsutism compared in the treatment group and control group'}], 'secondaryOutcomes': [{'measure': 'Plasma level of testosterone', 'timeFrame': '3 months', 'description': 'Plasma level of testosterone will be compared in the treatment group and control group'}, {'measure': 'Plasma level of insulin', 'timeFrame': '3 months', 'description': 'Plasma level of insulin will be compared in the treatment group and control group'}, {'measure': 'Plasma level of follicle-stimulating hormone (FSH)', 'timeFrame': '3 months', 'description': 'Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group'}, {'measure': 'Plasma level of luteinizing hormone (LH)', 'timeFrame': '3 months', 'description': 'Plasma level of luteinizing hormone will be compared in the treatment group and control group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Folic acid', 'PCOS', 'Insulin resistance', 'Infertility'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'An open clinical trial', 'detailedDescription': 'The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number will receive no folic acid'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'female patients suffering from PCOS-related subfertility', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will visit this centre suffering from PCOS-related subfertility will be invited to be enrolled to this study if met the Rotterdam criteria for the diagnosis of PCOS\n\nExclusion Criteria:\n\n* The patients whom will be excluded from the study are those comorbid with hyperprolactinemia, congenital adrenal hyperplasia, diabetes mellitus, significant cardiovascular problems, thyroid dysfunctions, unresolved medical conditions, or using medications suspected to affect reproductive or metabolic functions within two months of the study entry.'}, 'identificationModule': {'nctId': 'NCT03268733', 'acronym': 'FolicacidPCOS', 'briefTitle': 'The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Khartoum'}, 'officialTitle': 'The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS)', 'orgStudyIdInfo': {'id': 'Folic acid in PCOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': '45 PCOS patients will receive 5 mg folic acid', 'interventionNames': ['Drug: Folic Acid']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': '45 PCOS patients will receive no folic acid'}], 'interventions': [{'name': 'Folic Acid', 'type': 'DRUG', 'description': 'Tablet 5 mg', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Khartoum', 'status': 'RECRUITING', 'country': 'Sudan', 'contacts': [{'name': 'Mohammed ibrahim Awad', 'role': 'CONTACT', 'email': 'awad22mohd@gmail.com', 'phone': '00249900904060'}], 'facility': 'Saad Abul ella fertility Centre', 'geoPoint': {'lat': 15.55177, 'lon': 32.53241}}], 'centralContacts': [{'name': 'Mohammed Hassan Alnazeer', 'role': 'CONTACT', 'email': 'mhmd_nazir83@yahoo.com', 'phone': '00249912907268'}], 'overallOfficials': [{'name': 'Mohammed Hassan Alnazeer', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Khartoum'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'still undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Khartoum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Awad, Mohamed Ibrahim, M.D.', 'class': 'INDIV'}, {'name': 'Duria abdulwahab Elrrayes', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacist', 'investigatorFullName': 'Mohammed Hassan Alnazeer', 'investigatorAffiliation': 'University of Khartoum'}}}}